1. Field of the Invention
The present invention relates generally to urine collection devices and more particularly to a non-invasive female external urine collection device or catheter.
2. Description of the Prior Art
Hospitalized patients who are unable to control their urinary functions, or who, while being able to control their urinary functions, are unable physically to use a urinal or bed pan, are fitted with urine collection devices known as catheters. Male patients are provided with indwelling catheters only so long as urine volumes need to be monitored hour-to-hour, after which time they are switched to external catheters. Women, on the other hand, keep indwelling catheters as long as they remain unable to use normal facilities and frequently develop severe bladder infections.
While some non-hospitalized incontinent women wear indwelling catheters and take antibiotics for their bladder infections, others wear absorbent pads or diaper-like garments to soak up urine. However, in addition to being generally uncomfortable and of limited absorbent capacity, prolonged contact of such urine soaked pads or garments with the skin leads to skin irritation and in some cases ulceration of the skin.
There have been developed heretofor a number of female external urinals or urine collection devices; however, none of such devices has been completely satisfactory. Examples of one class of device are disclosed in U.S. Pat. No. 4,233,978 and U.S. Pat. No. 3,601,125, which broadly provide a collection receptacle that is positioned exterior of and seals completely around the patient's vulva. The device of the U.S. Pat. No. 4,233,978 is attached to the patient by means of an adhesive rim, while the device of the U.S. Pat. No. 3,601,125 is attached to the patient by means of a belt and strap arrangement. A shortcoming of both devices is that when they are used on a reclining patient, urine flows toward and may collect in the vagina, thereby leading to vaginal inflammation.
A further shortcoming in the U.S. Pat. No. 3,601,125 is in the method of attachment to the patient and in the considerable external bulk located between the patient's legs. In an attempt to provide a seal, substantial pressure must be applied by the belts to the device of the U.S. Pat. No. 3,601,125, which pressure can be damaging to tissue. Also, the external bulk of the device of the U.S. Pat. No. 3,601,125 may be uncomfortable to the wearer and may cause chafing or other irritation to the wearer's legs.
Another class of female external urine collection devices includes devices which are adapted to be positioned interior of the labia of the patient. One example of such a device is disclosed in U.S. Pat. No. 3,776,235. The device of the U.S. Pat. No. 3,776,235 includes a generally funnel-like collection chamber that is positioned on the patient by an intravaginal projection. The intravaginal projection is hollow and provides a flow path for ventilation and the passage of fluids to and from the vagina. However, the flow path communicates with the collection chamber and thereby, when used on reclining patients, provides a pathway for the flow of urine into the vagina and creates a substantial posterior leak.
Another such device is disclosed in U.S. Pat. No. 4,198,979, which includes a generally funnel-shaped, rigid collection means having a wide orifice with a flange thereabout. The wide orifice is sized to encompass both the urethral and vaginal orifices and the flange has mounted thereon a layer of body adhesive that is adapted to form a seal with the vestibule of the wearer interior of the labia minora. The labia minora contacts the underside of the flange and the exterior of the collection means to urge the flange and adhesive sealant into a more intimate contact with the vestibule of the patient. The preferred embodiment of the device of the U.S. Pat. No. 4,198,979 includes a pommel or projection that is adapted for insertion into and contact with the posterior side of the vagina.
The device of the U.S. Pat. No. 4,198,979 provides for the communication of urine to the vagina. The communication would appear to be accentuated in the preferred embodiment which includes the pommel. Additionally, the wide orifice allows substantially the entire area of the vestibule to be contacted with urine. Also, the tension placed by the device on the labia minora could result in stretching or other tissue damage.
In U.S. Pat. No. 4,270,539, there is disclosed a urine collection device which includes an interface body that engages the vestibule of the patient interior of the labia minora. The interface body includes a forward portion having a urine receiving bore and a rearward portion having a non-invasive vaginal seal. An absorbent pad is positioned about the interface body to absorb urine leaks. The device is held firmly against the user by a garment.
The device of the U.S. Pat. No. 4,270,539 must be custom made so as to fit the sizes and relative positions of the vaginal and urethral orifices of the patient. In order to form an effective vaginal seal, the device must be firmly urged against the tissue of the wearer, which could lead to irritation or tissue damage. Moreover, the vaginal seal, while being non-invasive, is occlusive in that it provides no ventilation to the vagina. The urine receiving portion of the device is not substantially leakproof and, indeed, a pad is provided for containing leaks.
A further female external urine collection device is disclosed in U.S. Pat. No. 3,613,122.
It is therefore an object of the present invention to provide a female external catheter that overcomes the shortcomings of the prior art. More specifically, it is an object of the present invention to provide a female external catheter that provides for the isolation of the urethral and vaginal openings but which is normally non-invasive of either the vagina or the urethra and which is non-occlusive of the vagina. It is a further object of the present invention to provide a female external catheter which provides for collection of substantially all urine passed by the patient, but which minimizes the amount of skin contacted by urine. It is a further object of the present invention to provide a female external catheter that is substantially universal in that one size and configuration fits substantially all women and need not be custom made. It is a further object of the present invention to provide a female external catheter that can be used effectively by walking, standing, seated, or reclining patients and which is of limited bulk and comfortable to the patient. It is a further object of the present invention to provide a female external catheter that is self supporting without pressure or substantial traction to the tissues and which may be worn without pads, belts, or supporting garments. It is a further object of the present invention to provide a female external catheter that is easy to apply and which may be self applied. It is yet a further object of the present invention to provide a female external catheter that is compatible with pre-existing drainage and collection devices. It is still another object of the present invention to provide a female external catheter that will allow a patient to "straight cath" herself without removing the device.